A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma

CONNected Electronic Inhalers Asthma Control Trial 2 (CONNECT 2), a 24-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study of Standard of Care Treatment Versus the eMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04677959

Acronym

CONNECT2

Enrollment

427

Registered

2020-12-21

Start date

2021-02-16

Completion date

2022-03-10

Last updated

2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

The primary objective of this study is to demonstrate the effectiveness of the Digital System (DS) in improving asthma control compared to the Standard of Care (SoC) group. The secondary objective is to describe the asthma management actions by investigational center health care providers (iHCPs) for all participants in both groups, to evaluate short-acting beta2 agonist (SABA) usage and the number of SABA-free days in the DS group, to evaluate adherence patterns to maintenance treatment (FS eMDPI) in the DS group, to assess behavioral correlates of responsiveness to digital health technology among participants for all participants in both groups, to evaluate work productivity and activity impairment in asthma participants in both groups, to assess the usability and acceptability of the DS by participants in the DS group and the investigational center personnel, and to evaluate the safety of FS eMDPI and Albuterol eMDPI.

Detailed description

Study duration will be approximately 27 weeks including a one-week screening period, 24 week treatment period, and a 2 week follow-up period.

Interventions

DRUGFluticasone propionate/salmeterol (FS)

FS administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard

DRUGAlbuterol

Albuterol administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard

DRUGStandard of Care Asthma Medication

Current inhaled corticosteroid(ICS)/Long-acting beta agonist(LABA) and any additional controller medication for asthma

DRUGStandard of Care Rescue Medication

Current rescue medication

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

Inclusion criteria

* The participant has a documented diagnosis of asthma established at the investigational center at the time of informed consent or the investigator confirms a diagnosis of asthma. * The participant is currently on treatment with a moderate- to high-dose inhaled corticosteroid (ICS) with long-acting beta agonist (LABA). * The participant has an Asthma Control Test score of less than 19 at the screening or baseline visit. * The participant is willing to discontinue all other maintenance ICS with LABA medications and rescue medications and replace them with the study-provided fluticasone propionate/salmeterol (FS) multidose dry powder inhaler with integrated electronic module (eMDPI) and Albuterol eMDPI, respectively, for the duration of the trial, if randomized to the Digital System group. All other asthma maintenance medications, except for ICS with LABA, may be continued. * Additional criteria apply, please contact the investigator for more information.

Exclusion criteria

* The participant is currently being treated prior to enrollment with a digital inhaler system, including the Digihaler system or an external bolt on digital system designed to monitor inhaler usage, such as the Propeller Health or Adherium systems. * The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma, which in the view of the investigator would preclude participation. * The participant was hospitalized for severe asthma in the last 30 days. * The participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study. * Additional criteria apply, please contact the investigator for more information.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control	Week 24	A well-controlled asthma was defined as an Asthma Control Test (ACT) score of greater than or equal to 20. Clinically important improvement in asthma control was defined by an increase of at least 3 ACT units from baseline. The ACT was a simple, participant-completed tool used for the assessment of overall asthma control. The ACT included 5 items that assessed daytime and nighttime asthma symptoms, use of reliever medication, and impact of asthma on daily functioning. Each item in the ACT was scored on a 5-point scale ranging from 1 (poor control of asthma) to 5 (well control of asthma), with summation of all items providing scores ranging from 5 to 25. The scores span the continuum of poor control of asthma (score of 5) to complete control of asthma (score of 25), with a cutoff score of 19 and below indicating participants with poorly controlled asthma.

Secondary

Measure	Time frame	Description
Number of Decreased Doses of Inhaled Medication	Baseline up to Week 24	Number of participants who received decreased dose of inhaled medication during the 24-week treatment period are reported.
Number of Increased Doses of Inhaled Medication	Baseline up to Week 24	Number of participants who received increased dose of inhaled medication during the 24-week treatment period are reported.
Number of Changes to Different Inhaled Medication	Baseline up to Week 24	Number of participants who received different inhaled medication during the 24-week treatment period are reported.
Number of Additional Inhaled Medication	Baseline up to Week 24	Number of participants who received additional inhaled medication during the 24-week treatment period are reported.
Change From Baseline in Mean Weekly SABA Usage at Week 24 for the DS Group	Baseline, Week 24	—
Change From Baseline in the Number of SABA-free Days at Week 24 for the DS Group	Baseline, Week 24	Number of days a participant did not use the rescue medication in a week are reported.
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy	Baseline up to Week 24	Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 24-week treatment period are reported.
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control	Baseline up to Week 24	Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence	Baseline up to Week 24	Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.
Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 24	Baseline, Week 24	The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ concern is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicated their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).
Change From Baseline in BMQ Necessity Subscale Score at Week 24	Baseline, Week 24	The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ necessity is a 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicated degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).
Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 24	Baseline, Week 24	The BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. Only one item assesses illness comprehensibility or coherence of illness (Item 7: How well do you feel you understand your illness?). This item was rated using a 0 (do not understand at all) to 10 (understand very clearly) response scale. A higher score indicates a stronger illness comprehensibility.
Change From Baseline in BIPQ Cognitive Subscale Score at Week 24	Baseline, Week 24	BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 5 items on cognitive representation of illness perception: consequences (Item 1: How much does your illness affect your life? Response range 0 \[no affect\] - 10 \[severe affect\]), timeline (Item 2: How long do you think your illness will continue? Response range 0 \[a very short time\] - 10 \[forever\]), personal control (Item 3: How much control do you feel you have over your illness? Response range 0 \[no control\] - 10 \[extreme amount of control\]), treatment control (Item 4: How much do you think your treatment can help your illness? Response range 0 \[not at all\] - 10 \[extremely helpful\]), and identity (Item 5: How much do you experience symptoms from your illness? Response range 0 \[no symptoms\] - 10 \[severe symptoms\]). Total BIPQ Cognitive Subscale Score was the sum of all item score and ranged from 0 to 50. A higher score indicates stronger illness perception.
Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 24	Baseline, Week 24	BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 2 items on emotional representation: concern (Item 6: How concerned are you about your illness? Response range 0 \[not at all concerned\] - 10 \[extremely concerned\]) and emotions (Item 8: How much does your illness affect you emotionally; for example, does it make you angry, scared, upset or depressed? Response range 0 \[not at all affected emotionally\] - 10 \[extremely affected emotionally\]). Total BIPQ Emotional Subscale Score was the sum of above 2 items score and ranged from 0 to 20. A higher score indicates extreme emotional representation.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24	Baseline, Week 24	WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.
System Usability Scale (SUS) Overall Score for DS Group	Week 24	The SUS was used to explore device acceptability and usability for participants in the DS group. It covered a variety of aspects of system usability, such as the need for support, training, and complexity, and thus giving a global view of subjective assessments of usability. It was a 10-question tool (with five response options; from 1=strongly disagree to 5=strongly agree) that provided a composite measure, ranging from 0 to 100, of the overall usability of the system being studied. Higher scores represent better usability level for the tool.
Number of Participants With Adverse Events (AEs)	Baseline up to Week 26	An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. Number of participants with any AEs, and device-related AEs has been reported.
Change From Baseline in Adherence to Maintenance Treatment (FS eMDPI) at Week 24 for the DS Group	Baseline, Week 24	Adherence to maintenance treatment was defined as the percentage of actual inhalation doses taken out of the total number of inhalation doses prescribed over the 24- week treatment period.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Standard of Care (SoC) Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.	185
Digital System (DS) Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.	242
Total	427

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	9
Overall Study	Lost to Follow-up	9	13
Overall Study	Non-compliance with study drug	0	2
Overall Study	Other than specified	0	8
Overall Study	Protocol deviation	0	11
Overall Study	Withdrawal by parent/guardian	0	1
Overall Study	Withdrawal by Subject	2	15

Baseline characteristics

Characteristic	Digital System (DS)	Total	Standard of Care (SoC)
Age, Continuous	46.9 years STANDARD_DEVIATION 18.36	46.8 years STANDARD_DEVIATION 18.06	46.7 years STANDARD_DEVIATION 17.72
Ethnicity (NIH/OMB) Hispanic or Latino	80 Participants	143 Participants	63 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	157 Participants	271 Participants	114 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants	13 Participants	8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Asian	6 Participants	13 Participants	7 Participants
Race/Ethnicity, Customized Black or African American	45 Participants	82 Participants	37 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants	2 Participants	1 Participants
Race/Ethnicity, Customized Not reported	4 Participants	6 Participants	2 Participants
Race/Ethnicity, Customized Other	1 Participants	2 Participants	1 Participants
Race/Ethnicity, Customized White	185 Participants	321 Participants	136 Participants
Sex: Female, Male Female	177 Participants	293 Participants	116 Participants
Sex: Female, Male Male	65 Participants	134 Participants	69 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 185	0 / 224
other Total, other adverse events	23 / 185	24 / 224
serious Total, serious adverse events	4 / 185	6 / 224

Outcome results

Primary

Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control

A well-controlled asthma was defined as an Asthma Control Test (ACT) score of greater than or equal to 20. Clinically important improvement in asthma control was defined by an increase of at least 3 ACT units from baseline. The ACT was a simple, participant-completed tool used for the assessment of overall asthma control. The ACT included 5 items that assessed daytime and nighttime asthma symptoms, use of reliever medication, and impact of asthma on daily functioning. Each item in the ACT was scored on a 5-point scale ranging from 1 (poor control of asthma) to 5 (well control of asthma), with summation of all items providing scores ranging from 5 to 25. The scores span the continuum of poor control of asthma (score of 5) to complete control of asthma (score of 25), with a cutoff score of 19 and below indicating participants with poorly controlled asthma.

Time frame: Week 24

Population: The modified intent-to-treat (mITT) analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Standard of Care (SoC)	Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control	112 Participants
Digital System (DS)	Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control	134 Participants

Comparison: The 95% credible intervals of the odds ratio from the posterior distributions were calculated and presented.

Secondary

Change From Baseline in Adherence to Maintenance Treatment (FS eMDPI) at Week 24 for the DS Group

Adherence to maintenance treatment was defined as the percentage of actual inhalation doses taken out of the total number of inhalation doses prescribed over the 24- week treatment period.

Time frame: Baseline, Week 24

Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
Standard of Care (SoC)	Change From Baseline in Adherence to Maintenance Treatment (FS eMDPI) at Week 24 for the DS Group	-10.87 percentage of inhalation	Standard Deviation 31.717

Secondary

Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 24

The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ concern is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicated their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).

Time frame: Baseline, Week 24

Arm	Measure	Value (MEAN)	Dispersion
Standard of Care (SoC)	Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 24	-0.8 units on a scale	Standard Deviation 3.34
Digital System (DS)	Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 24	-0.9 units on a scale	Standard Deviation 4.06

Secondary

Change From Baseline in BIPQ Cognitive Subscale Score at Week 24

BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 5 items on cognitive representation of illness perception: consequences (Item 1: How much does your illness affect your life? Response range 0 \[no affect\] - 10 \[severe affect\]), timeline (Item 2: How long do you think your illness will continue? Response range 0 \[a very short time\] - 10 \[forever\]), personal control (Item 3: How much control do you feel you have over your illness? Response range 0 \[no control\] - 10 \[extreme amount of control\]), treatment control (Item 4: How much do you think your treatment can help your illness? Response range 0 \[not at all\] - 10 \[extremely helpful\]), and identity (Item 5: How much do you experience symptoms from your illness? Response range 0 \[no symptoms\] - 10 \[severe symptoms\]). Total BIPQ Cognitive Subscale Score was the sum of all item score and ranged from 0 to 50. A higher score indicates stronger illness perception.

Time frame: Baseline, Week 24

Arm	Measure	Value (MEAN)	Dispersion
Standard of Care (SoC)	Change From Baseline in BIPQ Cognitive Subscale Score at Week 24	-2.5 units on a scale	Standard Deviation 5.51
Digital System (DS)	Change From Baseline in BIPQ Cognitive Subscale Score at Week 24	-3.3 units on a scale	Standard Deviation 6.83

Secondary

Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 24

BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 2 items on emotional representation: concern (Item 6: How concerned are you about your illness? Response range 0 \[not at all concerned\] - 10 \[extremely concerned\]) and emotions (Item 8: How much does your illness affect you emotionally; for example, does it make you angry, scared, upset or depressed? Response range 0 \[not at all affected emotionally\] - 10 \[extremely affected emotionally\]). Total BIPQ Emotional Subscale Score was the sum of above 2 items score and ranged from 0 to 20. A higher score indicates extreme emotional representation.

Time frame: Baseline, Week 24

Arm	Measure	Value (MEAN)	Dispersion
Standard of Care (SoC)	Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 24	-1.1 units on a scale	Standard Deviation 4.01
Digital System (DS)	Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 24	-1.3 units on a scale	Standard Deviation 3.98

Secondary

Change From Baseline in BMQ Necessity Subscale Score at Week 24

The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ necessity is a 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicated degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).

Time frame: Baseline, Week 24

Arm	Measure	Value (MEAN)	Dispersion
Standard of Care (SoC)	Change From Baseline in BMQ Necessity Subscale Score at Week 24	-0.4 units on a scale	Standard Deviation 3.27
Digital System (DS)	Change From Baseline in BMQ Necessity Subscale Score at Week 24	-1.3 units on a scale	Standard Deviation 3.86

Secondary

Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 24

The BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. Only one item assesses illness comprehensibility or coherence of illness (Item 7: How well do you feel you understand your illness?). This item was rated using a 0 (do not understand at all) to 10 (understand very clearly) response scale. A higher score indicates a stronger illness comprehensibility.

Time frame: Baseline, Week 24

Arm	Measure	Value (MEAN)	Dispersion
Standard of Care (SoC)	Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 24	-0.0 units on a scale	Standard Deviation 1.65
Digital System (DS)	Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 24	0.1 units on a scale	Standard Deviation 2.04

Secondary

Change From Baseline in Mean Weekly SABA Usage at Week 24 for the DS Group

Time frame: Baseline, Week 24

Arm	Measure	Value (MEAN)	Dispersion
Standard of Care (SoC)	Change From Baseline in Mean Weekly SABA Usage at Week 24 for the DS Group	-12.26 micrograms (μg)	Standard Deviation 59.199

Secondary

Change From Baseline in the Number of SABA-free Days at Week 24 for the DS Group

Number of days a participant did not use the rescue medication in a week are reported.

Time frame: Baseline, Week 24

Arm	Measure	Value (MEAN)	Dispersion
Standard of Care (SoC)	Change From Baseline in the Number of SABA-free Days at Week 24 for the DS Group	0.4 days	Standard Deviation 1.94

Secondary

Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24

WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.

Time frame: Baseline, Week 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Standard of Care (SoC)	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24	Absenteeism	-3.56 units on a scale	Standard Deviation 14.38
Standard of Care (SoC)	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24	Presenteeism	-10.98 units on a scale	Standard Deviation 24.5
Standard of Care (SoC)	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24	Work productivity loss	-12.18 units on a scale	Standard Deviation 26.25
Standard of Care (SoC)	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24	Activity impairment	-11.22 units on a scale	Standard Deviation 23.81
Digital System (DS)	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24	Activity impairment	-15.33 units on a scale	Standard Deviation 21.48
Digital System (DS)	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24	Absenteeism	-0.05 units on a scale	Standard Deviation 8.61
Digital System (DS)	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24	Work productivity loss	-9.87 units on a scale	Standard Deviation 19.16
Digital System (DS)	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24	Presenteeism	-10.43 units on a scale	Standard Deviation 18.57

Secondary

Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control

Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.